Identifiers
- 510(k) Number
- K823041 FDA 510(k)
- FDA Product Code
- IYM FDA 510(k)
Classification
- Device Class
- Class III FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.2980 FDA 510(k)
- Regulation Number
- 884.2980 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Jeol Model JTG-500M is a Telethermographic, Infrared System designed for medical imaging in obstetrics and gynecology. It employs infrared technology to capture thermal images, enabling non-invasive assessment of physiological conditions within the specified specialty.
This device is supplied as a reusable medical system and is classified under FDA regulation 884.2980 as a Class III product. It requires appropriate storage and maintenance in clinical settings, adhering to manufacturer guidelines for optimal performance. The device holds FDA 510(k) clearance (K823041) and is intended for use in environments where thermal imaging is applicable within obstetrics and gynecology.
Frequently asked questions
What clinical specialties is the Jeol Model JTG-500M primarily used for, and how does it work?
The Jeol Model JTG-500M is designed specifically for obstetrics and gynecology, where it uses infrared technology to capture thermal images. This non-invasive method allows clinicians to assess physiological conditions by analyzing heat patterns, helping evaluate areas like blood flow, tissue temperature, or potential abnormalities without direct contact or intervention.
Is the Jeol Model JTG-500M a single-use or reusable device, and what maintenance does it require?
The Jeol Model JTG-500M is a reusable medical system, meaning it is intended for repeated use in clinical settings. Since it is classified as a Class III device, it requires proper storage and maintenance as outlined by the manufacturer to ensure optimal performance and reliability over time. Regular cleaning and adherence to manufacturer guidelines are essential.
What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?
The Jeol Model JTG-500M received FDA 510(k) clearance (K823041) through a traditional review pathway, meaning it was determined to be substantially equivalent to a legally marketed device already on the market. This clearance confirms the device meets FDA safety and effectiveness standards for thermal imaging in obstetrics and gynecology, allowing its use in clinical settings where such imaging is applicable.
What is the product code and classification for this device under FDA regulations?
The Jeol Model JTG-500M is classified under FDA regulation 884.2980 and falls under the product code IYM. It is designated as a Class III device, which indicates it carries higher risk and requires strict regulatory oversight, including compliance with manufacturing and quality control standards.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K823041 | Class III | Active |
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Manufacturer
- Manufacturer
- Jeol
Sources (1)
- FDA 510(k) K823041 24 fields · synced Sep 18, 2026